Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

Genetic Predisposition Clinical Trial

Official title:

Genetic Counseling Service Delivery and Outcomes in Diverse and Underserved Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06212310
• Other study ID #: 2021-1008
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 2-arm prospective, randomized, controlled clinical trial compared outcomes of telephone genetic counseling (intervention) versus in-person genetic counseling (control) in an underserved, multilingual patient population referred for cancer genetic counseling at two North Texas safety-net hospitals.

The main question[s] it aims to answer are:

• Is telephone genetic counseling equal to in-person genetic counseling in the patient reported outcomes? Cancer genetics knowledge, attitude towards GT, and informed choice as well as GC-specific empowerment.

• Is telephone genetic counseling-based clinical outcomes the same as in-person genetic counseling for visit completion and testing rates? Participants will be randomized to either in-person or telephone genetic counseling arm and complete standard of care genetic counseling visit process where testing is offered. Both arms will complete a series of surveys to assess the outcomes of interest.

Description:

The overarching goal of this pilot prospective randomized controlled study is to compare patient-reported and clinical operations outcomes between in-person genetic counseling (IPGC - control) and telephone-based genetic counseling (TGC - intervention) in an indigent English or Spanish-speaking population seeking genetic counseling for hereditary cancer syndromes to create a framework for effective and efficient genetic service delivery in these populations nationally. General genetic education and principles will be conveyed through a standard genetic counseling session including a pre-test education video in both the TGC and IPGC arms. Our primary project objectives are to compare the following outcomes between the IPGC and TGC study arms. Aim 1: Patient reported outcomes - A. Patient satisfaction with genetic counseling visit; B. Knowledge of basic principles of cancer genetics and implications of genetic testing for personal healthcare and relatives. Secondary objectives for this aim are: 1. Patient ability to make informed choice; and 2. Genetic counseling-specific empowerment outcomes. Aim 2: Clinical outcomes - visit completion rate; Secondary objectives are: 1. Genetic testing completion rate; and 2. Genetic testing cancelation/failure rate. We hypothesize that patients in the TGC arm will not have significant differences in knowledge, satisfaction, informed choice or genetic counseling-specific empowerment compared to the IPGC arm. We also expect significantly increased visit completion rate and lower test completion rate in the TGC arm compared to the IPGC arm, but no significant difference in sample failure rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 31, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who are English or Spanish-speaking adults (18 years and older) already scheduled for cancer genetic counseling. Participants must either be uninsured or have Medicaid, and they must not have previously had germline genetic testing or cancer genetic counseling. Participants must have a working telephone number and valid e-mail address. Internet access is a requirement to complete electronic study surveys, receive study-related documents electronically.

Exclusion Criteria:

• Patients referred for surgical planning pending genetic test results. Minors (under age 18 years). Pregnant women. Decisionally impaired. Students/ residents. Patients who do not speak English or Spanish. Prisoners. Individuals without working telephone number and valid e-mail address or internet access.

Related Conditions & MeSH terms

• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Other:
• Telephone genetic counseling
genetic counseling service delivered audio-only

Locations

Country	Name	City	State
United States	Parkland Health	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Society of Genetic Counselors

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient reported outcome	Service satisfaction	Survey administered within 7 days of visit
Primary	Patient reported outcome	Genetic knowledge	Survey administered within 7 days of visit
Primary	Clinical outcome	Genetic counseling visit completion rate	Completion of visit on scheduled date
Secondary	Patient reported outcome	Informed choice for genetic testing	Survey administered within 7 days of visit
Secondary	Clinical outcome	Genetic testing completion rate	Testing must be complete within 90 days of visit
Secondary	Clinical outcome	Genetic test sample failure/cancelation rate	Within 90 days of visit